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CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bicalutamide and CP-675,206 (Tremelimumab)
Bicalutamide, CP-675,206 (tremelimumab)
Bicalutamide, CP-675,206 (Tremelimumab)
Bicalutamide, CP-675,206 (Tremelimumab)
Bicalutamide, CP-675,206
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Stage D0 Prostate Cancer, Rising PSA, Casodex, Tremelimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age & histologic diagnosis of adenocarcinoma of the prostate
  • Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease
  • Clinical Stage D0 prostate cancer with rising PSA and PSA >2ng/ml.
  • ECOG performance of <2
  • Normal hematologic, renal and liver function

Exclusion Criteria:

  • Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy.
  • No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide
  • No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis
  • No prior treatment with anti-CTLA 4 monoclonal antibody
  • No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C
  • No known brain metastases
  • No history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.

Sites / Locations

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3

Outcomes

Primary Outcome Measures

The Number of Participants Who Developed Cancer Antigen-specific Immune Responses

Secondary Outcome Measures

The Number of Participants With an Increase in PSA Doubling Time
Number of Participants With PSA Recurrence.
PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.

Full Information

First Posted
June 18, 2008
Last Updated
November 13, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00702923
Brief Title
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
Official Title
Phase I Dose Escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was halted prematurely due to slow accrual.
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.
Detailed Description
This is an open label, single-center Phase I study. All subjects will receive bicalutamide 150mg orally days 1-28. Subjects will receive CP-675,206 IV over one hour on day 29. Doses will range from 6 mg/kg to 15 mg/kg. This cycle will be repeated once at month 3. Once the maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Stage D0 Prostate Cancer, Rising PSA, Casodex, Tremelimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
Intervention Type
Drug
Intervention Name(s)
Bicalutamide and CP-675,206 (Tremelimumab)
Other Intervention Name(s)
Casodex, Tremelimumab
Intervention Description
Dose level -1 : Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 3 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Intervention Type
Drug
Intervention Name(s)
Bicalutamide, CP-675,206 (tremelimumab)
Other Intervention Name(s)
Casodex, Tremelimumab
Intervention Description
Dose level 1: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 6 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Intervention Type
Drug
Intervention Name(s)
Bicalutamide, CP-675,206 (Tremelimumab)
Other Intervention Name(s)
Casodex, Tremelimumab
Intervention Description
Dose level 2: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 10 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Intervention Type
Drug
Intervention Name(s)
Bicalutamide, CP-675,206 (Tremelimumab)
Other Intervention Name(s)
Casodex, Tremelimumab
Intervention Description
Dose level 3: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 15 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Intervention Type
Drug
Intervention Name(s)
Bicalutamide, CP-675,206
Other Intervention Name(s)
Casodex, Tremelimumab
Intervention Description
Final Dose Level: Bicalutamide 150 mg p.o. q.d. day 1-28, day 85-112 At month 9, if evidence of PSA progression: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 (MTD dose) I.V. over 1 hour, day 29
Primary Outcome Measure Information:
Title
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
Time Frame
Up to 12 months after treatment with study agent
Secondary Outcome Measure Information:
Title
The Number of Participants With an Increase in PSA Doubling Time
Time Frame
Up to 18 months after last dose of study agent
Title
Number of Participants With PSA Recurrence.
Description
PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.
Time Frame
one year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age & histologic diagnosis of adenocarcinoma of the prostate Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease Clinical Stage D0 prostate cancer with rising PSA and PSA >2ng/ml. ECOG performance of <2 Normal hematologic, renal and liver function Exclusion Criteria: Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy. No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis No prior treatment with anti-CTLA 4 monoclonal antibody No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C No known brain metastases No history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas McNeel, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer

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